Minister for Health brings EU Commission Delegated Regulation on Safety Features on Medicines into effect
The Minister for Health, Simon Harris TD, has today welcomed the implementation of the EU Commission Delegated Regulation (EU/2016/161) on Safety Features on medicinal products as part of the EU Falsified Medicines Directive.
The EU Regulation contains measures to combat the risk of falsified medicines entering the supply chain. It requires all pharma companies to put a unique 2D barcode and an anti-tampering device on packs of prescription medicines for the EU market. From 9 February 2019, people supplying medicines to patients must verify that the safety features of those medicines are in place by scanning the 2D barcode and checking the integrity of the anti-tamper device.
Speaking today, Minister Harris said “These new requirements will enhance patient safety by protecting the medicines supply chain from infiltration by counterfeit medicines and introducing new rules to more rigorously regulate the supply chain.
“While there has been no risk or reported incidents to date at pharmacy level from fake medicines in Ireland, other European countries have had issues. This new national system provides further security and protection for Irish and European patients now and into the future.”
To ensure an uninterrupted supply of medicines to patients, the initial emphasis will be on users learning to operate the system and regulators working with stakeholders to develop a clear and robust alerts management system. No offences provisions will be introduced and no enforcement action will be taken by regulatory authorities as the system beds in. Stakeholders must, however, take all steps necessary to ensure compliance with the EU Regulation. Enforcement provisions will be introduced later this year.
This approach will ensure that medicines continue to be provided to patients without delay and that manufacturers, marketing authorisation holders, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.
The Irish Medicines Verification Organisation (IMVO) has been established to manage the medicines verification system for Ireland and the Department of Health has been working closely with the IMVO, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the HSE and Private Hospitals Association (PHA) for the last year to monitor progress in the implementation of the new safety feature requirements across all sectors.
Leonie Clarke, IMVO General Manager, commented “This new medicines’ verification system, is a significant undertaking involving the collaboration of almost 2,000 pharmacies and hospitals, along with pharmaceutical manufacturers and wholesalers, stakeholder representatives and regulators, which sees over 95 million prescription medicines dispensed to patients every year.
“The new national system provides more safeguards and security to ensure Irish patients will continue to have absolute confidence in the medicines they receive from their pharmacy.”
Notes to the Editor
Following discussions at a national and European level with stakeholder representatives, it has been decided to adopt a pragmatic approach to the implementation of the Delegated Regulation (and the associated statutory instrument) after the go live date, to ensure the continuity of safe supply of medicines to patients while all parties gain a better understanding of the new system. This means that:
1. All medicinal products released by MAH’s for the Irish Market after 9 Feb 2019 should bear the safety features as required i.e. a tamper proof seal and 2D barcode.
2. During the initial period of operation, the system will be considered to be in ‘use and learn’ phase. Therefore wholesalers, pharmacies and hospitals should scan medicines bearing the safety features and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
3. All alerts generated by the FMD system on scanning a pack during this ‘use and learn’ phase will be forwarded by the system to the IMVO, the HPRA and the pharmaceutical companies so that they can be investigated and monitored.
4. Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.
National legislation including the provisions of Article 23 of the Delegated Regulation will be introduced, however, the offences provided for in the Regulations will not be commenced for a period of time to let the new system bed in.
During this period, the alerts generated will be analysed by the IMVO, HPRA, PSI, HSE and the private hospitals pharmacies to determine why they are occurring and develop appropriate protocols for their resolution. Manufacturers (and marketing authorisation holders) will also be involved in the investigation of alerts generated against their products. The system will be reviewed again in three months’ time.
This approach will ensure that medicines continue to be provided to patients without delay and also ensure that all stakeholders, manufacturers, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.
The Commission has published a Q&A document which addresses many of the key issues around implementation of the Delegated Regulation for Safety Features. The Department of Health advises all professionals expected to interact with the Regulation should read this document as well as the Commission’s dedicated Falsified Medicines webpage which provides additional relevant guidance.
Further background details are available from the Falsified Medicines sections of the IMVO, HPRA, PSI websites.